Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-derived drug, Spravato, for standalone therapy aimed at treating resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not respond to two or more other antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, expressed in a press release that many patients struggle for extended periods with various treatments that fail to alleviate their symptoms, significantly impacting their functioning and emotional well-being.
The recent application includes findings from a late-stage clinical trial indicating that Spravato, when used alone, could help reduce symptoms within as little as 24 hours and maintain effectiveness for at least four weeks.
Administered as a nasal spray, Spravato must be taken under medical supervision in a healthcare setting. Unlike traditional antidepressants, which often target the regulation of serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating communication between neurons.
In terms of sales performance, Spravato’s revenue surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by over 100,000 individuals across 77 countries, according to Johnson & Johnson.